药品领域中非常规检测项目(方法)的能力维护研究  

The Study on Capability Maintenance for Infrequency Testing Techniques in Medicinal Testing Field

作　　者：刘雅丹[1] 王朔威 刘燕[1] 姚令文[1] 常艳[1] 于健东[1] Liu Yadan;Wang Shuowei;Liu Yan;Yao Lingwen;Chang Yan;Yu Jiandong(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2023年第6期705-713,共9页Chinese Pharmaceutical Affairs

摘　　要：目的:针对认可过程中实验室在申请和维护非常规检测项目(方法)方面存在的问题与疑惑,提出适合于国内药品检测领域实验室运行此类检测活动的建议。方法:梳理国际标准化组织发布的准则要求和中国合格评定国家认可委员会出台的认可规则、认可准则及相关应用说明中涉及非常规检测项目(方法)的基本要求;概述并解读欧洲药品质量管理局针对此类检测项目所发布指南性文件中的关键内容;分析国内药品检测领域实验室中检测业务的动态变化特点等。结果与结论:在满足认可基本要求的前提下,探讨研究了在国内药品检测领域实验室中应用国际同行经验方式的可行性和适用性。尝试为相关实验室运行非常规检测项目(方法)提出合理化建议并拓展了质量管理思路。Objective:To propose the suitable suggestions for domestic medicinal testing laboratories running such testing activities based on the questions and doubts discovered in the process of accreditation in the laboratory in the application and maintenance of infrequently performed techniques.Method:To sort out the basic requirements on stated in guidelines issued by International Organization for Standardization and the accreditation regulations,criteria and relevant applications published by China National Accreditation Service for Conformity Assessment,to outline and interpret the key contents on such techniques in the guideline document published by European Directorate for the Quality of Medicines&HealthCare and to analyze the features,like the dynamic change,in the domestic medicinal testing laboratories.Results and Conclusion:Under the premise of meeting the basic requirements of accreditation,the research discovered the feasibility and plausibility of following the experiences method of international counterparts in domestic medicinal testing laboratories,attempted to provide extra possible advice for relevant laboratories to run infrequently performed techniques and expanded the scope of minds on quality management.

关 键 词：非常规检测项目(方法) 药品检测 标准要求 能力参数维护 

分 类 号：R95[医药卫生—药学]